HDI Clinical Trials Insurance

The insurer may not impose on the participant or his legal representative any nullity, any exemption or forfeiture of rights envisaged in law or in the insurance contract, except in the cases envisaged in legislation.

Scope of services at a glance

Non-fault liability insurance for Clinical Trials

HDI’s non-fault liability insurance for Clinical Trials provides the sponsors protection against claims made by participants, according to the Law of May 7th 2004. Coverage includes:

  • Non-fault insurance : the insurance will compensate for bodily injury and consequential losses, even without fault from the sponsor or the experimentation staff. However, the damage and the casual link between the clinical investigation and the damage must be established/proven.
  • Compliance with the Law of May 7th 2004 : no exclusion or limitation of liability can be imposed, except if foreseen by the legislation.


Integrated insurance solution

HDI’s non-fault liability insurance for Clinical Trials provides sponsors with an integrated insurance solution.

Coverage can be afforded for single trials (on case by case basis), or annually, for all trials started by the sponsor within the same territory, during the period of coverage.

International network

Insurance can be provided worldwide, according to the local requirements, in more than 50 countries.

Focus on accurate timeframe

Because the issuance of insurance certificates for Clinical Trials insurance is crucial for the sponsor to receive agreement from the local authorities, HDI commits itself to fast response.

Risk Consulting

Preparing for a possible emergency situation

HDI’s risk specialists in pharmacology provide the sponsors with support and advise. Among others, analysis of protocols or patient informed consents can lead to documents adaptations, necessary for approval by local authorities.

HDI can also assist the sponsors with local specificities.

Experts' Tip

With an extended international network and fast responding risk experts, HDI will bring you the support you need in submitting new studies to authorities. Why not talk to our experts?